In an effort to reduce the drug lag in Japan, in mid-September, the MHLW said, in general, Phase 1 drug clinical studies are not required before late-stage global studies. This notification will amend the prior notification in 2007 and render invalid a 2014 notification on the same topic. This future notification will emphasize that Phase 1 studies are not needed especially for drugs where there is a high demand like orphan and pediatric drugs.
Despite the above change, the MHLW still would like Phase 1 studies to be done in Japan for global studies in certain situations including when there is enough time to do them, the drug will be used by a huge number of Japanese patients, and where there is a likelihood of a large number of adverse events. Even when the new Phase 1 notification goes into effect, the MHLW recommends that companies still explore ethnic differences before regulatory submissions. In addition, this policy revision will not apply to Japanese-made drugs that originate in Japan.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------